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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Mini Back Hardware Extension Kit (pair). For use with MSMH. Extension kit allows offset height adjustment/installation of the Matrx Mini Back (±2.4" or ±3.6")
Motion Concepts Inc
MINI-EXT
In Commercial Distribution

  • 07540147000608 ()
MINI-EXT

  • Wheelchair back rest positioner
MX2 Removable Heavy-Duty Mounting Hardware (pair) for optional use with the Matrx MX2 Back. (Fits 3/4", 7/8" and 1" back canes). Quick-release design.
Motion Concepts Inc
IMX2QRH-HD
In Commercial Distribution

  • 07540147000295 ()
IMX2QRH-HD

  • Wheelchair back rest positioner
MX2 Fixed Heavy-Duty Mounting Hardware (pair) for optional use with the Matrx MX2 Back. (Fits 3/4", 7/8" and 1" back canes). Requires tools for removal.
Motion Concepts Inc
IMX2CFH-HD
In Commercial Distribution

  • 07540147000271 ()
IMX2CFH-HD

  • Wheelchair back rest positioner
Extended Range Mounting Hardware upgrade (pair). Provides additional 2" depth adjustment for PBMH and HDMH.
Motion Concepts Inc
ERMHU
In Commercial Distribution

  • 07540147000226 ()
ERMHU

  • Wheelchair back rest positioner
Fixed Space Saver Mounting Hardware (pair). (Fits 3/4", 7/8" and 1" back canes). Requires tools for removal. Permanent mount recommended for Power Wheelchair application or when portability is not required. Recommended for Tilt/Recline applications
Motion Concepts Inc
FSSH
In Commercial Distribution

  • 07540147000202 ()
FSSH

  • Wheelchair back rest positioner
A standalone HeRO monitor for two infants
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000234 ()


  • Neonatal/paediatric heart rate monitoring application software
  • Neonatal/paediatric heart rate monitoring hardware
A HeRO System for the private room
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000227 ()


  • Neonatal/paediatric heart rate monitoring application software
  • Neonatal/paediatric heart rate monitoring hardware
No Description
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000210 ()


  • Neonatal/paediatric heart rate monitoring application software
  • Neonatal/paediatric heart rate monitoring hardware
Server based HeRO System
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000203 ()


  • Neonatal/paediatric heart rate monitoring hardware
  • Neonatal/paediatric heart rate monitoring application software
The Prelude software supports radiation therapy workflows for IntraOp Mobetron, a radiation treatment device. It assists to find product specific machine parameters for treatment and can send those proposals to the console of the device. The machine parameters are not intended to be used for direct control for the radiation device.
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
V1. EBRT
In Commercial Distribution

  • 04260308110108 ()


  • Radiation therapy software
The Prelude software supports radiation therapy workflows for IntraOp Mobetron, a radiation treatment device. It assists to find product specific machine parameters for treatment and can send those proposals to the console of the device. The machine parameters are not intended to be used for direct control for the radiation device.
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
V1. IORT
In Commercial Distribution



  • Radiation therapy software
The Prelude software supports intra-operative radiation therapy workflows with intra-operative radiation devices like IntraOp Mobetron. It assists to find product specific machine parameters for treatment and can send those proposals to the intra-operative radiation device. The machine parameters are not intended to be used for direct control for the radiation device. Machine Output Quality can be visualized and recorded over time for quality assurance.
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
V1.
In Commercial Distribution

  • 04260308110078 ()


  • Radiation therapy software
No Description
L A P GMBH LASER APPLIKATIONEN
LUNA SGRT PC
In Commercial Distribution

  • 04260590372642 ()
0018346-0003

  • Radiological video camera patient positioning/tracking system
No Description
L A P GMBH LASER APPLIKATIONEN
LUNA Camera Pod
Not in Commercial Distribution

  • 04260590372604 ()
0018914

  • Radiological video camera patient positioning/tracking system
No Description
L A P GMBH LASER APPLIKATIONEN
LUNA Distribution Box
In Commercial Distribution

  • 04260590372581 ()
0018364-0008

  • Radiological video camera patient positioning/tracking system
No Description
DIERS International GmbH
n/a
In Commercial Distribution

  • 04260242060194 ()


  • Radiological video camera patient positioning/tracking system
No Description
DIERS International GmbH
II
In Commercial Distribution

  • 04260242060101 ()


  • Radiological video camera patient positioning/tracking system
No Description
DIERS International GmbH
III 4D
In Commercial Distribution

  • 04260242060019 ()


  • Radiological video camera patient positioning/tracking system
No Description
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
1.8
In Commercial Distribution

  • 04260308110023 ()


  • Radiation therapy software
No Description
L A P GMBH LASER APPLIKATIONEN
LUNA Camera Pod
In Commercial Distribution

  • 04260590372680 ()
0018365-0001

  • Radiological video camera patient positioning/tracking system
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